UDI is a unique numeric or alphanumeric code that consists of two parts:
(1) a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and (2)
a production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
(2a) the lot or batch number within which a device was manufactured; (2b) the serial number of a specific device; (2c) the expiration date of a specific device; (2d) the date a specific device was manufactured; (2e) the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.
| Device | |
| identifier | The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty. |
| displayName | |
| definition | |
| udiCarrier | |
| deviceIdentifier | The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. |
| issuer | All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency.
GS1 DIs:
http://hl7.org/fhir/NamingSystem/gs1
HIBCC DIs:
http://hl7.org/fhir/NamingSystem/hibcc
ICCBBA DIs for blood containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood
ICCBA DIs for other devices:
http://hl7.org/fhir/NamingSystem/iccbba-other |
| jurisdiction | |
| carrierAIDC | A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology. |
| carrierHRF | A unique device identifier (UDI) on a device label in plain text |
| entryType | |
| status | |
| availabilityStatus | |
| biologicalSourceEvent | |
| manufacturer | N/A |
| manufactureDate | The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”. |
| expirationDate | the expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”. |
| lotNumber | The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. |
| serialNumber | |
| name | |
| value | |
| type | |
| display | |
| modelNumber | |
| partNumber | |
| category | |
| type | |
| version | |
| type | |
| component | |
| installDate | |
| value | |
| conformsTo | |
| category | |
| specification | |
| version | |
| property | |
| type | |
| value[x] | |
| mode | |
| cycle | |
| duration | |
| owner | |
| contact | |
| location | |
| url | |
| endpoint | |
| gateway | |
| note | |
| safety | |
| parent | |